Phase 4
Completed N=24
Ziprasidone for Clozapine- or Olanzapine-Associated Diabetes Mellitus
Source: ClinicalTrials.gov NCT00351000 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcomePrimary: Change From Baseline in Fasting Glucose — 5; -4.5 mg/dL — p=0.956
Summary
This study is a six-week, open label trial of the novel antipsychotic agent, ziprasidone, added to a stable dose of clozapine or olanzapine in 40 diabetes mellitus patients, patients with an impaired fasting glucose or insulin resistance with schizophrenia or schizoaffective disorder. The first two weeks will be a fixed-dose of ziprasidone 40 mg twice a day. During weeks 2-6, the ziprasidone dose may be increased up to 80 mg twice a day.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Fasting Glucose |
5; -4.5 | 0.956 |
| PRIMARY Change From Baseline on Fasting Insulin |
1; -0.9 | 0.988 |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Schizophrenia, any subtype or schizoaffective disorder
- Ages 18-65 years
- Capable of providing informed consent
- Antipsychotic Agents -associated diabetes mellitus, impaired fasting glucose or insulin resistance
- Stable dose of clozapine or olanzapine for at least 1 month
- Optimal dose of clozapine or olanzapine, or a maximal dose if limited by significant side effects
Exclusion Criteria
- Serious medical or neurological illness (unstable cardiac disease including recent myocardial infarction or heart failure, seizure disorder, malignancy, liver or renal impairment, etc.)
- Current substance abuse
- Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile
- History of serious blood dyscrasia requiring discontinuation of clozapine
- Serious suicidal or homicidal risk within the past six months
- History of diabetes mellitus prior to treatment with clozapine or olanzapine
- H/o prolongation of QTc interval (>450) on EKG or clinically significant EKG abnormalities.
- Treatment with medications that significantly prolong QTc interval such as dofetilde, sotalol, quinidine, class Ia and III antiarrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacine, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyul acetate, dolasetron myselate, probucol, or tacrolimus.
Data sourced from ClinicalTrials.gov (NCT00351000). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.